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Effects of Diaphragm-releasing Techniques on the Lumbar Spine and Diaphragmatic Function in Healthy Women

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ClinicalTrials.gov Identifier: NCT03065283
Recruitment Status : Completed
First Posted : February 27, 2017
Results First Posted : April 7, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Pedro Olavo de Paula Lima, Universidade Federal do Ceara

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Healthy Individuals
Interventions Procedure: Diaphragm lift
Procedure: Relaxation of the diaphragm pillars
Enrollment 75
Recruitment Details  
Pre-assignment Details none declare
Arm/Group Title Diaphragmatic Release Diaphragmatic Release Control
Hide Arm/Group Description

The stretching of the peripheral fibers of the diaphragm

Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice

Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute

In both placebo techniques, only the light touching of the contacts of the volunteers' skin

Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice

Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute

Period Title: Overall Study
Started 50 25
Completed [1] 50 25
Not Completed 0 0
[1]
Outcomes were measured at baseline and after intervention. There was no dropoput of sample.
Arm/Group Title Diaphragmatic Release Diaphragmatic Release Control Total
Hide Arm/Group Description

The stretching of the peripheral fibers of the diaphragm

Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice

Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute

In both placebo techniques, only the light touching of the contacts of the volunteers' skin

Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice

Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute

Total of all reporting groups
Overall Number of Baseline Participants 50 25 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 25 participants 75 participants
21.24  (2.86) 21.12  (2.12) 21.18  (2.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 25 participants 75 participants
Female
50
 100.0%
25
 100.0%
75
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Thoracic Mobility
Hide Description Thoracic mobility was measued with a tape as an evaluation tool.
Time Frame baseline and immediately post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diaphragmatic Release Diaphragmatic Release Control
Hide Arm/Group Description:

The stretching of the peripheral fibers of the diaphragm

Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice

Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute

In both placebo techniques, only the light touching of the contacts of the volunteers' skin

Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice

Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute

Overall Number of Participants Analyzed 50 25
Mean (Standard Deviation)
Unit of Measure: cm
baseline 2.87  (0.93) 2.78  (1.08)
post-intervention 3.47  (1.00) 2.86  (0.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diaphragmatic Release, Diaphragmatic Release Control
Comments A paired t-test was used for intragroup analysis, and an independent Student’s t-test was used for intergroup analysis. Data are represented in mean between-group difference with a 95% CI, and analysis was by intention to treat.
Type of Statistical Test Equivalence
Comments p< or = 0.05
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.38 to 0.57
Estimation Comments [Not Specified]
2.Other Pre-specified Outcome
Title Amplitude of Motion of the Lumbar Spine
Hide Description Tape measure was used as an evaluation tool.
Time Frame baseline and immediately post-intervention
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Posterior Chain Flexibility
Hide Description Tape measure was used as an evaluation tool.
Time Frame baseline and immediately post-intervention
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Maximum Respiratory Pressure
Hide Description manovacuometer was used as an evaluation tool.
Time Frame baseline and immediately post-intervention
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diaphragmatic Release Diaphragmatic Release Control
Hide Arm/Group Description

The stretching of the peripheral fibers of the diaphragm

Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice

Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute

In both placebo techniques, only the light touching of the contacts of the volunteers' skin

Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice

Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute

All-Cause Mortality
Diaphragmatic Release Diaphragmatic Release Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Diaphragmatic Release Diaphragmatic Release Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diaphragmatic Release Diaphragmatic Release Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Dr. Pedro Lima
Organization: Department of Physical Therapy
Phone: 558533668091
EMail: pedrolima@ufc.br
Layout table for additonal information
Responsible Party: Pedro Olavo de Paula Lima, Universidade Federal do Ceara
ClinicalTrials.gov Identifier: NCT03065283    
Other Study ID Numbers: POdePLima2
First Submitted: February 6, 2017
First Posted: February 27, 2017
Results First Submitted: September 24, 2019
Results First Posted: April 7, 2020
Last Update Posted: April 16, 2020